Method of transradial catheterization, device for ulnar artery compression, and method of use

ABSTRACT

Disclosed are methods and devices for obtaining patent hemostasis of the radial artery by compressing the uninstrumented ulnar artery to increase radial artery flow. The device comprises a band having an inflatable bladder for applying blunt pressure to the ulnar artery. The method comprises applying a pressure to the homolateral ulnar artery and applying a pressure to the radial artery at the access site to obtain hemostasis at the access site.

BACKGROUND OF INVENTION

a. Field of Invention

The invention relates generally to transradial catheterization methodsand devices used in said methods. In particular, the invention concernsa method of obtaining patent hemostasis of the radial artery bycompressing the un-instrumented ulnar artery to increase radial arteryflow while applying pressure to the radial artery access site. Theinvention further concerns a device for applying blunt pressure to theulnar artery, and a method of use.

b. Description of Related Art

Radial artery instrumentation is becoming increasingly prevalent withcardiovascular procedures performed via transradial access, providingimprovement in outcomes, cost, as well as comfort. Radial arteryocclusion refers to the blockage of the radial artery. Radial arteryocclusion is a consequence of radial artery cannulation, whichobliterates the radial artery lumen, making it not available for accessin the future.

After instrumentation, it is necessary to compress the radial artery atthe access site to obtain hemostasis of the cannulation wound. Thecannulation wound is an opening of the wall of the radial artery.Hemostasis of the cannulation (or sheath) wound is accomplished byapplying blunt pressure to the radial artery at the cannulation woundsite, or access site. The application of this blunt pressure on theradial artery often causes the artery to occlude or close, therebydenying bloodflow further downstream within the radial artery.Maintaining blood flow in the radial artery while compressing the accesssite, after instrumentation, reduces the risk of post-instrumentationradial artery occlusion. Patent hemostasis is therefore understood tomean achieving the cessation of bleeding at the cannulation wound(access site) of the radial artery, while blood is allowed to flowthrough the artery.

The following references are representative of the field pertaining tothe present invention:

For example, U.S. Pat. No. 6,355,026 to Mick describes Right and leftcoronary catheters that are designed to be used in a transradialcoronary catheterization. Also discussed are methods of inserting thecatheters into a right or left coronary artery by a transradialapproach.

In an article entitled Efficacy and Safety of Transient Ulnar ArteryCompression to Recanalize Acute Radial Artery Occlusion AfterTransradial Catheterization (Am J Cardiol 2011; 107:1698-1701) IvoBernat, MD, and others, discuss a method directed to open an occludedradial artery after the radial artery becomes occluded. In the case ofradial artery occlusion, 3-4 hours after hemostasis of the radialartery, ulnar artery compression was applied to attempt recanalizationof radial artery. Bernat et. al. verified reopening of the radial arteryby administration of heparin and compression of the ulnar artery.

SUMMARY OF INVENTION

A present invention method of catheterization of the radial arterydirected at minimizing occurrences of radial artery occlusion isdisclosed. The method comprises inserting a sheath into the radialartery of a patient at an access site. The desired catheterizationprocedure is then performed using the sheath to access the radialartery. Once the catheterization procedure is complete, an ulnarpressure is applied to the homolateral ulnar artery at an ulnar pressuresite while the sheath remains inserted in the radial artery. The sheathis then removed from the radial artery while maintaining the ulnarpressure to the ulnar artery. Once the sheath is removed, and whilecontinuing to apply the ulnar pressure, pressure is applied to theradial artery at the access site to obtain hemostasis at the accesssite.

In a preferred embodiment, the step of “applying a pressure to theradial artery at the access site to obtain hemostasis at the accesssite” is accomplished while maintaining the ulnar pressure to the ulnarartery.

In an embodiment of the present invention, a further step includesconfirming that the step of applying ulnar pressure has reduced bloodflow through the ulnar artery by monitoring flow of the ulnar arteryprior to and after applying the ulnar pressure. In a further embodiment,monitoring flow of the ulnar artery includes sensing skin blood flowand/or pulsation at a fingertip or other location downstream of theulnar pressure site. Digital plethysmography is employed in a preferredembodiment.

In another embodiment, the method further includes confirming patency ofthe radial artery during the step of applying a pressure to the radialartery by sensing skin blood flow and/or pulsation at a fingertip orother location downstream of the access site. In this embodiment, thesensing is performed while the ulnar artery is fully compressed(allowing no flow through the ulnar artery) and/or partially compressed(allowing less flow than when not compressed at all). Patency isconfirmed, in an embodiment, by obtaining a metric relating to thesensing and comparing the metric with a standard metric for the patient,or with a previously-sensed metric. Preferably, the previously sensedmetric is read after the applying the ulnar pressure step and before thestep of removing the sheath from the radial artery. Digitalplethysmography is employed in a preferred embodiment.

In an embodiment of the present invention method, the step ofcompressing the ulnar artery includes: providing an ulnar impinger,securing the ulnar impinger over the wrist such that the impingercontacts a first location over the ulnar artery, and activating theimpinger to press on the ulnar artery at the first location.

In a preferred embodiment of the present invention, the step ofcompressing the ulnar artery includes: providing an ulnar impingementband having an inflatable bladder, securing the ulnar impingement bandover the wrist such that the bladder contacts a first location over theulnar artery, and inflating the bladder to impinge upon the ulnar arteryat the first location.

There is further disclosed a device for use in applying a compressingforce to the ulnar artery of a patient. The device includes a trunkhaving an inflatable bladder. The trunk is defined by a lower portionand an upper portion. The bladder is defined by an expandableenvelopment existing between the lower portion and the upper portion. Apair of limbs are connected to and extend from the upper portion of thetrunk. Together, the pair of limbs and the trunk form a general Y-shape.A first limb of the pair of limbs is adapted to lay across the palm of ahand, between the thumb and the index finger and connect to the trunk tosecure the first limb to the trunk and to secure the bladder to aportion of the patient's wrist corresponding with a first location overthe ulnar artery. A second limb of the pair of limbs is adapted to layover the wrist/distal forearm and connect to the trunk. This is tosecure the second limb to the trunk and to further secure the bladder tothe first location over the ulnar artery. One or more connectors areutilized for fixing the pair of limbs to the trunk.

In use, the bladder is located at the first location over the ulnarartery, and the pair of limbs are fixed around the hand and wrist to thetrunk with the connectors. The bladder is inflated with a tube connectedto an inflator to cause the bladder to impinge upon the ulnar artery atthe first location.

There is further disclosed a device for use in applying a compressingforce to the ulnar artery of a patient. The device comprises a trunkhaving an impinger. The trunk is defined by a lower portion and an upperportion. The impinger is defined by any device sufficient to apply acompression force. A pair of limbs are connected to and extend from theupper portion of the trunk. The pair of limbs together with the trunkform a general Y-shape. A first limb of the pair of limbs is adapted tolay across the palm of a hand, between the thumb and the index finger.The first limb connects to the trunk to secure the first limb to thetrunk, and also to secure the impinger to a portion of the patient'swrist corresponding with a first location over the ulnar artery. Asecond limb of the pair of limbs is adapted to lay over the wrist/distalforearm and connect to the trunk to secure the second limb to the trunkand to further secure the bladder to the first location over the ulnarartery. One or more connectors are employed to fix the pair of limbs tothe trunk. In use, the impinger is located at the first location overthe ulnar artery. The pair of limbs are fixed around the hand and wristto the trunk with the connectors. The impinger is activated to cause thebladder to impinge upon the ulnar artery at the first location.

Additional features, advantages, and embodiments of the invention may beset forth or are apparent from consideration of the following detaileddescription, drawings, and claims. Moreover, it is to be understood thatboth the foregoing summary of the invention and the following detaileddescription are exemplary and intended to provide further explanationwithout limiting the scope of the invention as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are included to provide a furtherunderstanding of the invention and are incorporated in and constitute apart of this specification, illustrate preferred embodiments of theinvention and together with the detailed description serve to explainthe principles of the invention. In the drawings:

FIG. 1 is schematic layout of methods disclosed herein;

FIG. 2 is a plan view of the ulnar impingement device according to anembodiment of the present invention;

FIG. 3 is a view showing the ulnar impingement device applied to apatient according to an embodiment of the present invention;

FIG. 4 is another view showing the bladder or impinger of the ulnarimpingement device applied to a patient according to an embodiment ofthe present invention;

FIG. 5 is a view showing the ulnar impingement device applied to apatient showing the top of the hand according to an embodiment of thepresent invention;

FIG. 6 is an isometric view of the ulnar impingement device shown withtrunk fastened to the pair of limbs.

DETAILED DESCRIPTION OF THE EMBODIMENTS

The invention is directed to a method of obtaining patent hemostasis ofthe radial artery by compressing the un-instrumented ulnar artery toincrease radial artery flow while applying pressure to the radial arteryaccess site. The invention further concerns a device for applying bluntpressure to the ulnar artery, and a method of use.

A present invention method of catheterization of the radial arterydirected at minimizing occurrences of radial artery occlusion isdisclosed. Referring to FIG. 1 specifically, and the Figures in general,the method 1000 comprises inserting a sheath into the radial artery of apatient at an access site. A sheath, as disclosed herein, is understoodto encompass any device inserted into the radial artery and used topermit the access of instrumentation into the radial artery. The desiredcatheterization procedure is then performed using the sheath to provideinstrumentation access the radial artery.

Once the catheterization procedure is complete, an ulnar pressure isapplied to the homolateral ulnar artery at an ulnar pressure site whilethe sheath remains inserted in the radial artery. The sheath is thenremoved from the radial artery while maintaining the first pressure tothe ulnar artery. Once the sheath is removed, and while continuing toapply the ulnar pressure, pressure is applied to the radial artery atthe access site to obtain hemostasis at the access site.

In a preferred embodiment, the step of “applying a pressure to theradial artery at the access site to obtain hemostasis at the accesssite” is accomplished while maintaining the first pressure to the ulnarartery.

The radial artery and the ulnar artery are the two conduits for the flowof oxygenated blood to the hand. The arteries are interconnected andtherefore form an interdependent flow network. When flow is reduced inone of the arteries, by compression for example, flow increases in theother artery. When the ulnar artery is compressed, flow in the ulnarartery is reduced, which causes an increase in pressure and flow in theradial artery.

In an embodiment, a further step includes confirming that theapplication of ulnar pressure has reduced blood flow through the ulnarartery. This is done by monitoring flow of the ulnar artery prior to andafter applying the ulnar pressure. In a further embodiment, monitoringflow of the ulnar artery includes sensing skin blood flow and/orpulsation at a fingertip or other location downstream of the ulnarpressure site. Digital plethysmography is employed in one embodiment.

In another embodiment, the method 1000 further includes confirmingpatency of the radial artery during the step of applying a pressure tothe radial artery. In a preferred embodiment, patency is accomplished bysensing skin blood flow and/or pulsation at a fingertip or otherlocation downstream of the access site. Other sensing locations bothupstream and downstream may be used to confirm patency of the radialartery. In the preferred embodiment, the sensing is performed while theulnar artery is fully compressed (allowing no flow through the ulnarartery) and/or partially compressed (allowing less flow than when notcompressed at all). Patency is confirmed, in an embodiment, by obtaininga metric relating to the sensing and comparing the metric with astandard metric for the patient, or with a previously-sensed metric.Metric is understood to mean a sensible, quantifiable value or reading,relating to the characteristic sensed. Preferably, the previously sensedmetric is read after the applying the ulnar pressure step and before thestep of removing the sheath from the radial artery. Digitalplethysmography is employed, in a preferred embodiment, to obtain themetrics. Other sensing modes may be employed, so long as the selectedmode is capable of confirming patency in one form or another.

In an embodiment of the present invention method 1000, the step ofcompressing the ulnar artery includes: providing an ulnar impinger,securing the ulnar impinger over the wrist such that the impingercontacts a first location over the ulnar artery, and activating theimpinger to press on the ulnar artery at the first location. In apreferred embodiment, the first location is over the Guyon's canal,demarcated by pisiform bone on the medial aspect, directly over theulnar artery pulse.

Impinger is understood to include any device capable of applying a forceto the ulnar artery, whether alone or part of a system, sufficient tocompress the ulnar artery. One exemplary class includes mechanicaldevices that expand in size to cause a band surrounding the wrist toconstrict an object to compress the ulnar artery. Another exemplaryclass of impingers includes mechanical devices that constrict a bandworn around the wrist sufficient to cause an object to press on theulnar artery.

In a preferred embodiment, the step of compressing the ulnar arteryincludes: providing an ulnar impingement band having an inflatablebladder, securing the ulnar impingement band over the wrist such thatthe bladder contacts a first location over the ulnar artery, andinflating the bladder to impinge upon the ulnar artery at the firstlocation.

Turning to the Figures generally, and particularly FIGS. 2-6, there isfurther disclosed a device 11 for use in applying a compressing force tothe ulnar artery of a patient. The device 11 includes a trunk 13 havingan inflatable bladder 15. The trunk 13 is defined by a lower portion 13a and an upper portion 13 b. The bladder 15 is defined by an envelopment17 existing between the lower portion 13 a and the upper portion 13 b. Apair of limbs 19 are connected to and extend from the upper portion 13 bof the trunk 13. Together, the pair of limbs 19 and the trunk 13 form ageneral Y-shape. Preferably, the pair of limbs 19 and the trunk 13 areplanar and form a Y-shape band. A first limb 19 a of the pair of limbs19 is adapted to lay across the palm of a hand, between the thumb andthe index finger. The first limb 19 a is adapted to connect to the trunk13 for securing the first limb 19 a to the trunk 13 and for securing thebladder 15 to a portion of the patient's wrist corresponding with afirst location 25 over the ulnar artery. A second limb 19 b of the pairof limbs 19 is adapted to lay over the wrist/distal forearm and connectto the trunk 13. This is to secure the second limb 19 b to the trunk 13and to further secure the bladder 15 to the first location 25 over theulnar artery. One or more connectors 21 are utilized for fixing the pairof limbs 19 to the trunk 13. In a preferred embodiment, the connector isVelcro.

In use, the bladder 15 is located at the first location 25 over theulnar artery, and the pair of limbs 19 are fixed around the hand andwrist to the trunk 13 with the connectors 21. The bladder 15 is inflatedwith a tube connected to an inflator to cause the bladder 15 to impingeupon the ulnar artery at the first location 25.

There is further disclosed a device 13 for use in applying a compressingforce to the ulnar artery of a patient. The device 13 comprises a trunk13 having an impinger 23. The trunk 13 is defined by a lower portion 13a and an upper portion 13 b. The impinger 23 is defined by any devicesufficient to apply a compression force. Examples include expandingsprings, expanding screw-type appurtenances, or other devices andsystems as discussed herein. A pair of limbs 19 are connected to andextend from the upper portion 13 b of the trunk 13. The pair of limbs 19together with the trunk 13 form a general Y-shape. A first limb 19 a ofthe pair of limbs 19 is adapted to lay across the palm of a hand,between the thumb and the index finger. The first limb 19 a connects tothe trunk 13 to secure the first limb 19 a to the trunk 13, and also tosecure the impinger 23 to a portion of the patient's wrist correspondingwith a first location 25 over the ulnar artery. A second limb 19 b ofthe pair of limbs 19 is adapted to lay over the wrist/distal forearm andconnect to the trunk 13 to secure the second limb 19 b to the trunk 13and to further secure the impinge 23 to the first location over theulnar artery. One or more connectors 21 are employed to fix the pair oflimbs 19 to the trunk 13. In use, the impinger 23 is located at thefirst location 25 over the ulnar artery. The pair of limbs 19 are fixedaround the hand and wrist to the trunk 13 with the connectors 21. Theimpinger 23 is activated to cause the impinger 23 to impinge upon theulnar artery at the first location 25.

The invention claimed is:
 1. A method of obtaining patent hemostasis ofa radial artery of a patient after performing a catheterizationprocedure using a sheath to access the radial artery wherein the sheathis inserted into the radial artery at an access site, comprisingperforming the following steps in sequence: (i) applying hemostaticpressure to the radial artery while simultaneously increasing radialartery flow by applying an ulnar pressure to an ulnar artery at an ulnarpressure site; (ii) maintaining continued partial compression of theulnar artery, thereby maintaining an increased flow of blood inside theradial artery, at least until hemostasis of the radial artery isachieved.
 2. The method of claim 1, further comprising means forapplying the ulnar pressure to the ulnar artery.
 3. The method of claim1, wherein the ulnar pressure site is a Guyon's canal.
 4. The method ofclaim 1, further comprising monitoring patency of the radial artery bysensing.
 5. The method of claim 4, further comprising confirming patencyof the radial artery while applying pressure to the radial artery toobtain hemostasis at the access site.
 6. The method of claim 1, whereinapplying the ulnar pressure to the ulnar artery comprises: providing anulnar impinger, securing the ulnar impinger over a wrist such that theimpinger contacts the ulnar pressure site, and activating the impingerto press on the ulnar artery at the ulnar pressure site.
 7. The methodof claim 1, wherein applying the ulnar pressure to the ulnar arterycomprises: providing a band having an inflatable bladder, securing theband over a wrist such that the bladder contacts the ulnar pressuresite, and inflating the bladder to compress the ulnar artery at theulnar pressure site.
 8. The method of claim 5, wherein the step ofconfirming patency further comprises the use of digital plethysmography.9. The method of claim 4, wherein the sensing is performed downstream ofthe access site.
 10. The method of claim 4, wherein the sensing isperformed upstream of the access site.
 11. The method of claim 6,wherein the ulnar impinger comprises of a mechanical device with aconstricting band worn around the wrist sufficient to cause an object topress on the ulnar artery.
 12. The method of claim 7, wherein the bandhaving the inflatable bladder comprises: a trunk having said inflatablebladder, the trunk defined by a lower portion and an upper portion, andthe bladder defined by an envelopment existing between the lower portionand the upper portion; a pair of limbs connected to and extending fromthe upper portion of the trunk, the pair of limbs together with thetrunk forming a general Y-shape; a first limb of the pair of limbsadapted to lay across the palm of a hand, between the thumb and theindex finger and connect to the trunk to secure the first limb to thetrunk and to secure the bladder to a portion of the patient's wristcorresponding with the ulnar pressure site; a second limb of the pair oflimbs adapted to lay over the wrist/distal forearm and connect to thetrunk to secure the second limb to the trunk and to further secure thebladder on the ulnar pressure site; one or more connectors for fixingthe pair of limbs to the trunk; wherein the bladder is located at theulnar pressure site, and the pair of limbs are fixed around the hand andwrist to the trunk with the connectors, the bladder is inflated with atube connected to an inflator to cause the bladder to impinge upon theulnar pressure site.
 13. The method of claim 1 further comprising thestep of removing the ulnar pressure to the ulnar artery.
 14. The methodof claim 13 wherein the step of removing the ulnar pressure to the ulnarartery is performed after hemostasis of the radial artery is achieved.15. A method of obtaining hemostasis of a radial artery of a patientafter performing a catheterization procedure at an access site of theradial artery, comprising performing the following steps: (a) applyinghemostatic pressure to the radial artery while simultaneously increasingradial artery flow by applying an ulnar pressure to an ulnar artery atan ulnar pressure site; (b) maintaining continued partial compression ofthe ulnar artery while achieving cessation of bleeding at the accesssite of the radial artery; (c) attaining hemostasis of the radialartery; and (d) removing pressure to the ulnar artery, wherein steps (a)and (b) precede step (c).
 16. The method of claim 15 wherein the step(c) is accomplished while continuing to apply the ulnar pressure to theulnar artery and step (d) is performed after step (c).
 17. The method ofclaim 15, wherein applying the ulnar pressure to the ulnar arterycomprises: providing a band having an inflatable bladder, securing theband over a wrist such that the bladder contacts the ulnar pressuresite, and inflating the bladder to compress the ulnar artery at theulnar pressure site.
 18. The method of claim 15, wherein applying thecontinued partial compression of the ulnar artery thereby allows lessflow through the ulnar artery than when the ulnar artery is notcompressed at all.
 19. The method of claim 15, further comprisingmonitoring patency of the radial artery by sensing.